Glucose Monitoring, ContinuousNCT07402382
Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri/Post-Menopausal Women
A study testing Amylopectin-chromium blend and Concentrated Amylopectin-chromium blend in people with Glucose Monitoring, Continuous and Whole Body Protein Metabolism, run by Nutrition 21, Inc. at 1 site in United States.
Trial summary
The goal of this study is to better understand how an amylopectin chromium blend may influence whole body protein balance in women during midlife, when hormonal changes can adversely affect protein metabolism and muscle maintenance. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Monitoring, Continuous, Whole Body Protein Metabolism, Peri-menopausal Women
- What is being tested?
- Amylopectin-chromium blend and Concentrated Amylopectin-chromium blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 40-65 years who meet either of the following menstrual-history criteria:
- ≥ 60 days but < 12 months of amenorrhea (late perimenopause)
- Women with ≥ 12 months of spontaneous amenorrhea (post-menopausal)
- No more than 3 days per week of structured physical activity
- Provide voluntary signed and dated informed consent.
- Be in good health and able to participate in an exercise bout as determined by assessment, medical history, and routine blood chemistries.
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- Between the of 40 and 65 years of age (inclusive).
- Body Mass Index of 18.5-34.9 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- Normal supine, resting heart rate (<90 per minute).
- Subject agrees to follow standardized controlled diet for 3 days and maintain existing dietary patterns on other days throughout the study period.
- Subject is willing and able to comply with the study protocol.
- Able to provide an adequate blood draw.
- If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study. Note: A generic multivitamin is allowed.
- Refrain from caffeine, exercise, and alcohol for 24 hours prior, and fast for 10 hours prior to each visit.
Who cannot join
- Current use of any dietary ingredient that impacts glucose control or insulin sensitivity.
- Current vegans or vegetarians.
- Intolerance to dairy foods/drinks.
- Smokes more than 10 cigarettes per day or uses other nicotine products (i.e. vape, patch) that deliver a similar amount of nicotine.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband, etc.).
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- Individuals using any kind of GLP-1 medications.
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- Individuals who have gained or lost more than 10 pounds within the last 30 days.
- Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Chronic medically diagnosed inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
- Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
- Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: Effects of an Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose Control in Peri/Post-Menopausal Women
The goal of this study is to better understand how an amylopectin chromium blend may influence whole body protein balance in women during midlife, when hormonal changes can adversely affect protein metabolism and muscle maintenance. Continuous glucose monitoring will also be used to assess glycemic control over a 24-hour period.
The main questions the study aims to answer are:
Read more
- Does the use of an amylopectin chromium blend in peri- and post-menopausal women help to support positive protein balance
- Can the affect be achieved using a concentrated dose
Researchers will compare the nutritional supplement to a placebo (amylopectin alone) to see if the amylopectin chromium blend can promote positive protein balance. A concentrated dose of the supplement will also be evaluated for comparative effectiveness.
Participants will:
- Consume the nutritional supplement (standard or concentrated dose) or placebo acutely after a short resistance exercise bout
- Complete four in-person visits, including the single-day intervention
Results from this research may help guide future nutritional strategies to support healthy aging, muscle function, and overall metabolic health.
Read the detailed description
This randomized, double-blind, placebo-controlled clinical trial will evaluate the effects of two dosage forms of an amylopectin-chromium blend on whole-body protein balance in peri- and post-menopausal women. The study will employ a stable isotope tracer methodology to quantify acute changes in protein synthesis and breakdown following a standardized resistance exercise bout and protein ingestion. Continuous glucose monitoring will assess the impact of the supplement on glycemic control over a 24-hour period.
Approximately 60 apparently healthy women, aged 40-65 years, will be enrolled at a single clinical site (The Center for Applied Health Sciences, Canfield, OH). Participants will complete four in-person visits over a 2-3-week period: one screening visit and three testing visits. Following screening and baseline assessments (including clinical chemistry, complete blood count, lipid panel, vital signs, and body composition via bioimpedance analysis), eligible participants will be randomly assigned to one of three groups:
- Amylopectin-chromium blend, 2 g co-ingested with 20 g of protein from yogurt,
- Concentrated Amylopectin-chromium blend, 100 mg, co-ingested with 20 g of protein from yogurt, or
- Placebo (2 g amylopectin) co-ingested with 20 g of protein from yogurt.
Each participant will receive only one product dose during the study. Group assignment will be randomized and blinded to both participants and investigators.
Prior to dosing, participants will undergo exercise familiarization and 5-repetition-maximum testing for leg press and leg extensions. At Visit 3 (Day 5), participants will ingest a single oral dose of ¹⁵N-alanine (2 g) as a metabolic tracer, and then will perform a standardized resistance exercise protocol (3 × 12-15 repetitions each of leg press and leg extension at 60-65 % of estimated 1RM, with 2-minute rest intervals). Immediately following exercise, the assigned study product with yogurt protein will be ingested. A second 20 g yogurt protein serving will be consumed with the evening meal to maintain uniform post-exercise protein intake.
Urinary nitrogen enrichment (¹⁵N-urea) will be measured from 24-hour urine collections (0-12 h and 12-24 h) to determine protein turnover rates. Blood samples obtained at multiple time points will assess biochemical responses, including blood urea nitrogen and isotope enrichment. Whole-body protein synthesis and breakdown will be calculated from tracer kinetics. Continuous glucose monitoring will capture interstitial glucose fluctuations.
Throughout the study, participants will follow a controlled diet standardized for energy and macronutrient content (approximately 1.1 g protein/kg body weight/day) and will abstain from alcohol, caffeine, and strenuous exercise for 24 hours before each visit. Compliance with dietary controls will be verified using the ASA24 or USDA Food Data Central tools.
Adverse events, vital signs, and anthropometrics will be monitored at each visit. The total blood volume collected will be approximately 38 mL. No major safety risks are anticipated; potential discomforts include mild gastrointestinal upset, muscle soreness from resistance exercise, and transient local effects from blood draws.
The primary study outcomes are changes in whole-body protein synthesis and breakdown measured by ¹⁵N-alanine tracer methodology. Secondary outcomes include indices of glucose control, derived from continuous glucose monitoring, and safety/tolerability endpoints.
This study will provide mechanistic insight into the acute effects of the amylopectin-chromium blend on whole-body protein balance in peri- and post-menopausal women, contributing to the broader understanding of nutritional interventions that support muscle health and metabolic function during midlife.
- Conditions
- Glucose Monitoring, Continuous, Whole Body Protein Metabolism, Peri-menopausal Women, Post-menopause
- Being tested
- Amylopectin-chromium blend, Concentrated Amylopectin-chromium blend, Placebo
- Keywords
- Glucose, protein metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amylopectin-chromium blendDietary supplement
Amylopectin-chromium blend, 2 g
Concentrated Amylopectin-chromium blendDietary supplement
Amylopectin-chromium blend in a concentrated format (100 mg)
PlaceboDietary supplement
Amylopectin, 2 g
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| Active 1 | Experimental | Standard dose Receives: Dietary Supplement: Amylopectin-chromium blend |
| Active 2 | Experimental | Concentrated dose Receives: Dietary Supplement: Concentrated Amylopectin-chromium blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-Body Protein Turnover (Protein Synthesis and Breakdown)
This study will evaluate the effect of a dietary supplement consumed with protein and resistance exercise on whole-body protein turnover in healthy adults. Whole-body protein synthesis and breakdown will be assessed using a stable isotope tracer methodology following ingestion of a non-radioactive, isotope-labeled amino acid. Urine and blood samples will be collected over a 24-hour period to quantify protein turnover in response to the intervention.
Measured: 24 hours
Secondary outcomes (1)
Interstitial Glucose Concentration measured using 24-24-hour continuous glucose monitoring
Interstitial glucose concentrations will be measured continuously using a blinded continuous glucose monitoring system worn on the upper arm. Glucose data will be collected over a 6-day monitoring period and used to derive summary measures including mean glucose concentration and indices of glycemic variability, pre- and post-intervetion
Measured: Day 0 to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Monitoring, ContinuousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrition 21, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Responsible party
- Sponsor
- Investigators
- Tim Ziegenfuss, PhD, Principal investigator, The Center for Applied Health Sciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402382
- Sponsor's protocol ID
- EH-01-2025
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose Control in Peri/Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT07402382
- Acronym / sponsor ID
- EH-01-2025
- Conditions
- Glucose Monitoring, Continuous, Whole Body Protein Metabolism, Peri-menopausal Women, Post-menopause
- Keywords
- Glucose, protein metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nutrition 21, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to better understand how an amylopectin chromium blend may influence whole body protein balance in women during midlife, when hormonal changes can adversely affect protein metabolism and muscle maintenance. Continuous glucose monitoring will also be used to assess glycemic control over a 24-hour period.
The main questions the study aims to answer are:
- Does the use of an amylopectin chromium blend in peri- and post-menopausal women help to support positive protein balance
- Can the affect be achieved using a concentrated dose
Researchers will compare the nutritional supplement to a placebo (amylopectin alone) to see if the amylopectin chromium blend can promote positive protein balance. A concentrated dose of the supplement will also be evaluated for comparative effectiveness.
Participants will:
- Consume the nutritional supplement (standard or concentrated dose) or placebo acutely after a short resistance exercise bout
- Complete four in-person visits, including the single-day intervention
Results from this research may help guide future nutritional strategies to support healthy aging, muscle function, and overall metabolic health.
Detailed description
This randomized, double-blind, placebo-controlled clinical trial will evaluate the effects of two dosage forms of an amylopectin-chromium blend on whole-body protein balance in peri- and post-menopausal women. The study will employ a stable isotope tracer methodology to quantify acute changes in protein synthesis and breakdown following a standardized resistance exercise bout and protein ingestion. Continuous glucose monitoring will assess the impact of the supplement on glycemic control over a 24-hour period.
Approximately 60 apparently healthy women, aged 40-65 years, will be enrolled at a single clinical site (The Center for Applied Health Sciences, Canfield, OH). Participants will complete four in-person visits over a 2-3-week period: one screening visit and three testing visits. Following screening and baseline assessments (including clinical chemistry, complete blood count, lipid panel, vital signs, and body composition via bioimpedance analysis), eligible participants will be randomly assigned to one of three groups:
- Amylopectin-chromium blend, 2 g co-ingested with 20 g of protein from yogurt,
- Concentrated Amylopectin-chromium blend, 100 mg, co-ingested with 20 g of protein from yogurt, or
- Placebo (2 g amylopectin) co-ingested with 20 g of protein from yogurt.
Each participant will receive only one product dose during the study. Group assignment will be randomized and blinded to both participants and investigators.
Prior to dosing, participants will undergo exercise familiarization and 5-repetition-maximum testing for leg press and leg extensions. At Visit 3 (Day 5), participants will ingest a single oral dose of ¹⁵N-alanine (2 g) as a metabolic tracer, and then will perform a standardized resistance exercise protocol (3 × 12-15 repetitions each of leg press and leg extension at 60-65 % of estimated 1RM, with 2-minute rest intervals). Immediately following exercise, the assigned study product with yogurt protein will be ingested. A second 20 g yogurt protein serving will be consumed with the evening meal to maintain uniform post-exercise protein intake.
Urinary nitrogen enrichment (¹⁵N-urea) will be measured from 24-hour urine collections (0-12 h and 12-24 h) to determine protein turnover rates. Blood samples obtained at multiple time points will assess biochemical responses, including blood urea nitrogen and isotope enrichment. Whole-body protein synthesis and breakdown will be calculated from tracer kinetics. Continuous glucose monitoring will capture interstitial glucose fluctuations.
Throughout the study, participants will follow a controlled diet standardized for energy and macronutrient content (approximately 1.1 g protein/kg body weight/day) and will abstain from alcohol, caffeine, and strenuous exercise for 24 hours before each visit. Compliance with dietary controls will be verified using the ASA24 or USDA Food Data Central tools.
Adverse events, vital signs, and anthropometrics will be monitored at each visit. The total blood volume collected will be approximately 38 mL. No major safety risks are anticipated; potential discomforts include mild gastrointestinal upset, muscle soreness from resistance exercise, and transient local effects from blood draws.
The primary study outcomes are changes in whole-body protein synthesis and breakdown measured by ¹⁵N-alanine tracer methodology. Secondary outcomes include indices of glucose control, derived from continuous glucose monitoring, and safety/tolerability endpoints.
This study will provide mechanistic insight into the acute effects of the amylopectin-chromium blend on whole-body protein balance in peri- and post-menopausal women, contributing to the broader understanding of nutritional interventions that support muscle health and metabolic function during midlife.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| Active 1 | Experimental | Dietary Supplement: Amylopectin-chromium blendStandard dose |
| Active 2 | Experimental | Dietary Supplement: Concentrated Amylopectin-chromium blendConcentrated dose |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- ≥ 60 days but < 12 months of amenorrhea (late perimenopause)
- Women with ≥ 12 months of spontaneous amenorrhea (post-menopausal)
Key exclusion criteria (14 listed)
- Current use of any dietary ingredient that impacts glucose control or insulin sensitivity.
- Current vegans or vegetarians.
- Intolerance to dairy foods/drinks.
- Smokes more than 10 cigarettes per day or uses other nicotine products (i.e. vape, patch) that deliver a similar amount of nicotine.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amylopectin-chromium blendAmylopectin-chromium blend, 2 g | Dietary supplement | Active 1 |
| Concentrated Amylopectin-chromium blendAmylopectin-chromium blend in a concentrated format (100 mg) | Dietary supplement | Active 2 |
| PlaceboAmylopectin, 2 g | Dietary supplement | Placebo |
Primary outcome
Whole-Body Protein Turnover (Protein Synthesis and Breakdown)
Time frame: 24 hours
This study will evaluate the effect of a dietary supplement consumed with protein and resistance exercise on whole-body protein turnover in healthy adults. Whole-body protein synthesis and breakdown will be assessed using a stable isotope tracer methodology following ingestion of a non-radioactive, isotope-labeled amino acid. Urine and blood samples will be collected over a 24-hour period to quantify protein turnover in response to the intervention.
1 secondary outcome
Interstitial Glucose Concentration measured using 24-24-hour continuous glucose monitoring
Time frame: Day 0 to day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Ziegenfuss, PhD principal investigator
The Center for Applied Health Sciences, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amylopectin-chromium blend and Concentrated Amylopectin-chromium blend in people with Glucose Monitoring, Continuous and Whole Body Protein Metabolism, run by Nutrition 21, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Ziegenfuss, Ph.D. (330-926-6927, tz@appliedhealthsciences.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-Body Protein Turnover (Protein Synthesis and Breakdown) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.